CTRI Number |
CTRI/2015/08/006100 [Registered on: 17/08/2015] Trial Registered Retrospectively |
Last Modified On: |
13/08/2015 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Biological Surgical/Anesthesia Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Extraction socket preservation procedure using platelet rich fibrin with and without calcium phosphate cement |
Scientific Title of Study
|
Comparative evaluation of socket preservation procedure using platelet rich fibrin with and without calcium phosphate cement– A Clinico-Radiographic Study. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Nihal Devkar |
Designation |
Reader |
Affiliation |
Sinhgad Dental College and Hospital, Pune |
Address |
Sinhgad Dental College and Hospital, Vadgaon Budruk, Off Sinhgad Road, Pune
Pune MAHARASHTRA 411041 India |
Phone |
|
Fax |
|
Email |
drdevkar@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shwetambari Navale |
Designation |
P.G Student |
Affiliation |
Sinhgad Dental College and Hospital, Pune |
Address |
Sinhgad Dental College and Hospital, Vadgaon Budruk, Off Sinhgad Road, Pune
Pune MAHARASHTRA 411041 India |
Phone |
|
Fax |
|
Email |
shweta2747@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Nihal Devkar |
Designation |
Reader |
Affiliation |
Sinhgad Dental College and Hospital, Pune |
Address |
Sinhgad Dental College and Hospital, Vadgaon Budruk, Off Sinhgad Road, Pune
Pune MAHARASHTRA 411041 India |
Phone |
|
Fax |
|
Email |
drdevkar@gmail.com |
|
Source of Monetary or Material Support
|
IFGL REFRACTORIES LTD.
Unit 1 sector A kalunga industrial estate, Kalunga-770031
dist: sundergarh, Odisha |
|
Primary Sponsor
|
Name |
Sinhgad Dental College and Hospital |
Address |
Dept of Periodontology, Room No.4, Vadgaon Budruk, Off Sinhgad Road, Pune 411041 |
Type of Sponsor |
Private medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Nihal Devkar |
Sinhgad Dental College and hospital |
Department of periodontology, Room No.4, Vadgaon Budruk, Off Sinhgad Road, Pune Pune MAHARASHTRA |
9420481441
drdevkar@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Sinhgad Dental College and Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Systemically healthy patients between the age group 20-45 years
having at least two non-molar teeth indicated for extraction., |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Calcium phosphate Cement |
Calcium phosphate cement, dose-0.5cc
Route-direct delivery to the extraction site
assessment duration-6 months |
Comparator Agent |
platelet rich fibrin |
platelet rich fibrin autologous, obtained from a dose of 10 ml intravenous blood,
Route- direct delivery to the extraction site.
assessment duration- 6 months |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
Systemically healthy patients between the age group 20- 45 years
Patients having at least two non-molar teeth indicated for extraction.
Indications for extraction include either root fracture, endodontic treatment failure, or non-restorable carious teeth.
Alveolar sockets with 4 wall architecture.
Patients willing to participate and sign an informed consent. |
|
ExclusionCriteria |
Details |
Patients who are systemically compromised.
Patients having history of smoking or tobacco habit.
Patients on medications that impair hematological parameter.
Patient having history of bone disorder.
Teeth having acute periapical or periodontal pathology.
Pregnant and lactating females.
Extraction sockets with one or more bony walls damaged. |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Clinical and Radiographic of
a. Marginal bone levels, calculated using a Williams periodontal probe as the distances between the coronal border of the stent and the mid-buccal and the mid-palatal aspect of the alveolar bone crest.
b. The bucco-palatal width will be measured using a surgical caliper at mid-buccal and mid-palatal aspect of the socket at 1mm, 3mm and 5mm apical to the bone crest.
Time point-at 6 months |
Time point-at 6 months
|
|
Secondary Outcome
|
Outcome |
TimePoints |
none |
none |
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
03/02/2014 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
1. Orgeas GV, Clementini M, Risi VD, Sanctis Md. Surgical techniques for alveolar socket preservation: A systemic review. Int J Oral Maxillofac Implants 2013;28:1049-10.
2. Aimetti M, Romano F, Griga FB, Godia L. Clinical and histological healing of human extraction sockets filled with calcium sulphate. Int J Oral Maxillofac Implants 2009;24:901-909.
3. Behnam Shakibaie-M. Comparison of the effectiveness of two different bone substitute materials for socket preservation after tooth extraction: A controlled clinical study. Int J Periodontics Restorative Dent 2013;33:223-228.
4. Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants 2009;24:260-271.
5. Horowitz R, Holtzclaw D, Rosen PS. A review on alveolar ridge preservation following tooth extraction. J Evid Base Dent Pract 2012; SI: 149-1
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
After extraction, severe hard and soft
tissue alteration takes place within the affected site of alveolar ridge.1
The three dimensional resorption process at extraction sites results in
narrower ridges and reduced vertical height and lingual/palatal shifting of
their long axis. Most of the dimensional alterations take place in the first 3
months following tooth removal.2
In the first 12 months after extraction,
the height of alveolar ridge can diminish upto 50% because the alveolar bone
resorbs especially on the buccal aspect.3 This change may lead to esthetic and
functional disadvantages that compromise future implant placement particularly
if the dental implant placement needs to be delayed for 6 months or longer.
Hence it is crucial to preserve the dimensions and
contour of the alveolar ridge after tooth extraction to achieve a predictable
esthetic and functional prosthetic restoration. Preservation of the residual alveolar
socket at the time of tooth extraction has been evaluated in many studies. Clinical, histologic and radiographic studies
documented positive socket healing responses with autogenous bone, alloplasts
and xenografts, whereas others reported poor results with bovine bone,
decalcified freeze dried bone & autogenous bone.1, 4, 5, 6, 7, 8 Since they are associated with varying
amounts of vital bone socket fill, comparison studies are useful to determine
the amount of socket preservation that occurs with each material. A new class
of alloplast materials, namely, calcium phosphate cements (CPC) raised certain
hopes in periodontal repair in the early 1990s.
These are aqueous based cements that get converted to hydroxyapatite
upon setting. The combination of biocompatibility,
osteoconductivity and restorability makes it a unique material for grafting
bony defects.9 Platelet rich fibrin (PRF) is an
autologous preparation of concentrated platelets created by centrifugation of a
patient’s blood. The use of PRF during
surgical procedure is a current treatment concept used to accelerate wound
healing and tissue maturation. It can be
used directly as a clot or after compression as a strong membrane. 10
Based on these positive findings of calcium
phosphate cement and platelet rich fibrin, the purpose of this study is to
compare clinical and radiographic [Cone Beam Computed Tomography (CBCT)]
outcomes following grafting for post extraction ridge preservation in sites
treated with platelet rich fibrin with or without calcium phosphate cement. Aim: To compare the use of platelet rich
fibrin (PRF) with and without calcium phosphate cement in fresh extraction
sockets by clinical and radiographic analyses. Objectives: 1. To
evaluate horizontal and vertical ridge changes associated with PRF used with
and without CPC at baseline and after 6 months using clinical and radiographic methods. 2. To
compare horizontal and vertical ridge changes associated with PRF used with and
without CPC using clinical and radiographic methods.
3. To
evaluate and compare the radiographic density changes associated with PRF used
with and without CPC. |